Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects

Donna S Cox, Daniel F Alvarez, Amy E Bock, Carol L Cronenberger, Donna S Cox, Daniel F Alvarez, Amy E Bock, Carol L Cronenberger

Abstract

This open-label, single-dose, randomized, parallel-group, 2-arm phase 1 bioequivalence (BE) study assessed the pharmacokinetics (PK), safety, and tolerability of PF-06410293 (ADL-PF), an adalimumab (ADL) biosimilar, following administration by prefilled pen (PFP) or prefilled syringe (PFS). A total of 164 healthy adult subjects were randomized (1:1) to receive ADL-PF (40 mg subcutaneously) in the lower abdomen or upper anterior thigh by PFS or PFP; 163 subjects were included in the primary PK analysis. The concentration-time profiles of the ADL-PF PFS and PFP treatment arms were similar. The 90% confidence intervals for the test/reference ratios of the primary end points (area under the serum concentration-time profile from time 0 to 2 weeks after dosing and maximum observed serum concentration) fell within the 80.00%-125.00% prespecified margin for BE. Comparable numbers of subjects experienced adverse events (AEs) between treatment groups, and injection-site pain was similar at all times and for the 2 injection-site locations. This study demonstrated the BE of ADL-PF following subcutaneous administration using either a PFS or PFP device. ADL-PF by PFS or PFP injection was well tolerated, with the distribution of AEs, including injection-site reactions, being similar between treatment arms.

Trial registration: ClinicalTrials.gov NCT02572245.

Keywords: PF-06410293; adalimumab; bioequivalence; pharmacokinetics.

Conflict of interest statement

Donna Cox, Daniel Alvarez, and Amy Bock are employees of and hold stock or stock options from Pfizer. Carol Cronenberger was an employee of and held stock or stock options from Pfizer at the time the study was conducted.

© 2021 Pfizer Inc. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.

Figures

Figure 1
Figure 1
Study design. aSubjects with an unresolved AE that was possibly related to ADA formation were asked to return for ADA and drug concentration blood sampling at up to 3‐month intervals until the AE or its sequelae resolved or stabilized at a level acceptable to the investigator and the sponsor concurred with the investigator's assessment. Visits continued up to 6 months from the visit on day 43 or the day of early withdrawal. ADA, antidrug antibody; ADL‐PF, PF‐06410293; AE, adverse event; CRU, clinical research unit; EOS, end of study; FU, follow‐up; PFP, prefilled pen; PFS, prefilled syringe; PK, pharmacokinetics.
Figure 2
Figure 2
Mean serum concentration‐time profiles of ADL‐PF (40 mg subcutaneously) by PFS or PFP in healthy subjects. ADL‐PF, PF‐06410293; PFP, prefilled pen; PFS, prefilled syringe.

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Source: PubMed

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